BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE LUER ACCESS

    MDR report key: 17633792 · Received August 28, 2023

    Report

    Report Number
    1710034-2023-00949
    Event Type
    Malfunction
    Date Received
    August 28, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 29, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    00382903851003
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 07-SEP-2023. INVESTIGATION SUMMARY: BD RECEIVED A Q-SYTE CLOSED LUER ACCESS DEVICE FROM LOT 2182891 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED NO PHYSICAL DEFECT OR DEFORMITIES. NEXT, THE ENGINEER PERFORMED A LEAK TEST ON THE RETURNED UNIT AND A FEW DROPS OF MEDIA WERE SEEN DRIPPING FROM THE VENT HOLE. FINALLY, THE ENGINEER REMOVED THE DEVICE'S SEPTUM AND INSPECTED IT FOR ANY POTENTIAL DAMAGE. THE ENGINEER IDENTIFIED A HOLE IN THE BOTTOM DISK THAT CREATED A PATHWAY FOR FLUID TO FLOW THROUGH INSTEAD OF BEING BLOCKED. THEREFORE, BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT OCCURRED DUE TO A MISALIGNMENT BETWEEN THE SEPTUM AND THE MANUFACTURING EQUIPMENT.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD Q-SYTE LUER ACCESS IT WAS CRACKED AND LEAKING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: FEEDBACK FROM NURSE PRACTITIONER OF CRACKED JOINTS AND FLUID LEAKS FOUND DURING USE. PREPARED TO USE A SPLIT DIAPHRAGM NEEDLELESS CLOSED INFUSION CONNECTOR FOR A PATIENT AT 10:45 A.M. THE CONNECTOR WAS FOUND TO BE CRACKED, OOZING, AND NOT FUNCTIONING PROPERLY; IT WAS REPLACED WITH ANOTHER INFUSION CONNECTOR AND CONTINUED TO BE USED, WITH NO ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD Q-SYTE LUER ACCESS IT WAS CRACKED AND LEAKING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: FEEDBACK FROM NURSE PRACTITIONER OF CRACKED JOINTS AND FLUID LEAKS FOUND DURING USE. PREPARED TO USE A SPLIT DIAPHRAGM NEEDLELESS CLOSED INFUSION CONNECTOR FOR A PATIENT AT 10:45 A.M. THE CONNECTOR WAS FOUND TO BE CRACKED, OOZING, AND NOT FUNCTIONING PROPERLY; IT WAS REPLACED WITH ANOTHER INFUSION CONNECTOR AND CONTINUED TO BE USED, WITH NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252347 BD Q-SYTE LUER ACCESS INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2182891 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown